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FDA 510(k) Application Details - K002503
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K002503
Device Name
System, Monitoring, Perinatal
Applicant
ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY, MA 01960 US
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Contact
STEVEN A CLARKE
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/14/2000
Decision Date
11/09/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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